Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT05996536

Feasibility of Adipose Tissue Triglyceride (TG) Labelling in Familial Partial Lipodystrophy (FPLD)

Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12

14

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: People with familial partial lipodystrophy (FPLD) do not store fat in the body normally. This can lead to serious illnesses such as diabetes and heart disease. To learn more about FPLD, researchers want to compare the fat tissue in people with this disease to the fat tissue of healthy people. Objective: To collect and analyze samples of fat tissue in people with and without FPLD. Eligibility: People aged 18 to 65 years with FPLD. Healthy adults are also needed. Design: Participants will be screened. They will have a physical exam. The size and shape of their body will be measured. They will have an imaging scan to measure their bones, muscle, and fat. Participants will be given heavy water to drink at home. The water contains a tracer to help measure the fat in their blood. They will drink 1 vial 3 times a day. After drinking the water for 9 days, participants will come to the clinic for a 3-day stay. They will eat only foods provided by the hospital; the foods will contain tracers. A needle will be inserted into a vein in the arm; participants will receive infusions of other tracers through this needle into their blood; this needle will also be used to draw blood samples for testing. On their third day in the clinic, participants will have biopsies: Small samples of fat will be removed from under the skin on the belly and thigh. Participants may return for a follow-up visit 8 days after leaving the clinic. Blood draws and fat tissue biopsies will be repeated.

CONDITIONS

Official Title

Feasibility of Adipose Tissue Triglyceride (TG) Labelling in Familial Partial Lipodystrophy (FPLD)

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willingness to comply with all study procedures and be available for the study duration
  • Age between 18 and 65 years
  • Agreement to follow lifestyle considerations during the study
  • Weight stability within approximately 3 kg in the 3 months before screening with no plans to change weight
  • Clinical diagnosis of partial lipodystrophy showing reduced fat in some body areas with preserved fat in others
  • Adequate abdominal and thigh fat tissue for biopsy as judged by the investigator
Not Eligible

You will not qualify if you...

  • Uncontrolled diabetes with HbA1C above 8% at screening
  • Use of insulin secretagogues (sulfonylureas) within one week before the first study visit
  • Changes in insulin dose greater than 30% in the two weeks before the first study visit
  • Use of niacin within one week before the first study visit
  • Use of antiplatelet medications that cannot be safely stopped before biopsies
  • Chronic use of anticoagulant medications that cannot be safely stopped before biopsies
  • Non-fasting triglycerides above 1000 mg/dL at screening
  • Kidney dysfunction with GFR less than 60 mL/min/1.73 m2 at screening
  • Following extreme diets like ketogenic, paleo, or Atkins
  • Positive pregnancy test or breastfeeding at screening
  • History of HIV, hepatitis B, or hepatitis C infection
  • History of acquired lipodystrophy
  • Significant abnormalities in thyroid, liver, blood counts, or minerals at screening
  • Inability to comply with study procedures
  • Inability or unwillingness to provide informed consent
  • Any condition increasing risk, preventing compliance, or affecting study results as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

M

Megan S Startzell, R.N.

CONTACT

R

Rebecca J Brown, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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